As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company. This month, Merck completed the spinoff, creating Organon. Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets. Organon…
On Thursday Theramex announced that it has entered into an agreement to register and commercialize denosumab, a biosimilar of Enzene Bioscience’s Prolia®, which treats osteoporosis by decreasing bone absorption. The agreement licenses Theramex to market the drug for use in Europe and Australia. Enzene will exclusively supply the finished product…
Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA). According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…
On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version of HUMIRA® (adalimumab). AbbVie’s first action was brought in the Northern District of Illinois on April 27, 2021. We previously…
As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were…
Biogen Inc. and Bio-Thera Solutions, Ltd. today announced positive Phase 3 results on BAT1806, a proposed biosimilar to ACTEMRA®/RoACTEMRA (tocilizumab). According to the Biogen press release, the study met its primary endpoints, demonstrating equivalent efficacy and comparable safety to the reference product in patients with moderate to severe rheumatoid arthritis…
An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis). The authors concluded from this study that both biosimilars…
On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs. The announcement stated that similar to other Canadian jurisdictions, Quebec will eventually cover, with exceptions, only biosimilar drugs on the…
On May 21, 2021, Meiji Seika Pharma Co, Ltd. announced that phase I clinical trials of DMB-3115, its proposed ustekinumab (STELARA®) biosimilar, demonstrated bioequivalence to reference products marketed in Europe and the United States. Meiji is co-developing ustekinumab under a 2011 strategic collaboration partnership agreement with Dong-A Socio Holdings. Phase III…
On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar. The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer. The drug is made…